The FDA has alerted healthcare providers to a recall of two intracranial pressure monitoring kits manufactured by Integra LifeSciences due to potential corrosion on the included 14-gauge Tuohy needle.
The recall applies to the Codman Microsensor Basic Kit and the Cerelink ICP Sensor Basic Kit, according to the March 16 alert. Integra notified customers of the issue Dec. 12, 2025, recommending that identified lots be immediately removed from use or distribution.
The company said the needle corrosion could result in inflammation, toxic response, infection or fever, all potentially requiring medical intervention. No long-term patient follow-up is required if the devices have already been used. Integra has reported one serious injury and no deaths associated with the defect.
Customers and distributors were instructed to quarantine affected lots and coordinate returns through Integra’s customer service team. The FDA classified the recall as one that may cause temporary or potentially serious health problems.
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